FIT CHECKER ADVANCED

K110871 · GC America, Inc. · ELW · Jun 17, 2011 · Dental

Device Facts

• Record ID: K110871
• Device Name: FIT CHECKER ADVANCED
• Applicant: GC America, Inc.
• Product Code: ELW · Dental
• Decision Date: Jun 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Indications for Use

Checking fit of crowns, bridges, veneers, inlays and dentures.

Device Story

GC Fit Checker Advanced is a silicone-based dental impression material used to identify high spots and pressure points on crowns, bridges, veneers, inlays, and dentures. The device consists of a base silicone paste and a catalyst silicone, delivered via tubes or a cartridge system. It combines technology from previous Fit Checker products with vinyl polyether silicone impression material to enhance hydrophilicity. The material is applied by a dental professional in a clinical setting to the prosthetic or oral site; it spreads uniformly and sets in the moist oral environment. Its translucency allows clinicians to visually examine the thickness of the material layer to assess prosthetic fit. By identifying areas of interference, the device assists the clinician in adjusting the restoration to achieve an optimal fit, reducing the need for repeated trial-and-error adjustments.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4823 standards. Results: Detail reproduction 20μm (meets requirement); Elastic recovery 98.9–99.3% (meets requirement ≥96.5%); Strain in compression 4.2–4.5% (meets requirement 2.0–20%).

Technological Characteristics

Silicone impression material (base and catalyst). Features improved hydrophilicity and translucency. Dimensions/form factor: tube or cartridge delivery. Testing performed per ISO 4823. No electronic components or software.

Indications for Use

Indicated for checking the fit of dental prosthetics including crowns, bridges, veneers, inlays, and dentures in patients requiring dental restoration assessment.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Fit Checker II (K032289)
• GC Fusion Fast (Exa'lence) (K043471)
• GC Fusion (Exa'lence) (K041398)
• HYDROFLEX (K973343)

Submission Summary (Full Text)

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Section 6 - 510(k) Summary

K110871

#### Submitter Information: 1.

GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803

| Contact Person: | Mark Heiss, D.D.S. |
|-----------------|--------------------|
| Phone: | [phone] |
| Fax: | [phone] |

March 24, 2010 Date Prepared:

Device Name: 2.

| Proprietary Name: | GC Fit Checker Advanced |
|------------------------|----------------------------|
| Classification Name: | Dental Impression material |
| Device Classification: | 872.3660 |
| Product Code: | ELW |

Substantial equivalence for the medical device is based on comparison to the following devices:

| Product | Applicant | 510(k) No. | Code No. |
|-----------------------------|-----------------|------------|----------|
| Fit Checker II | GC AMERICA, INC | K032289 | ELW |
| GC Fusion Fast (Exa'lence)* | GC AMERICA, INC | K043471 | ELW |
| GC Fusion (Exa'lence)* | GC AMERICA, INC | K041398 | ELW |
| HYDROFLEX | GC AMERICA, INC | K973343 | ELW |

* Due to trademark issues, product was renamed Exa'lence from Fusion/Senn. FDA notified August 18, 2009.

- 3. Device description and Intended Use
GC Fit Checker Advanced is a silicone impression material intended to check fit by detecting the high spots and pressure points of crowns, bridges, veneers, inlays and dentures.

- 4. Components and Mode of Action
GC Fit Checker Advanced has two types of packaging/delivery systems in which the base silicone paste and the catalyst silicone are filled. One is in tubes and the other is a cartidge device, similar to silicone impression material.

Fit Checker Advanced was developed combining the technology of Fit Checker and vinyl polyether silicone impression material, EXA'Lence, to achieve higher hydrophilicity. Due to the improved hydrophilicity, the material easily and uniformly spreads and sets sharply under moist oral environment. The optimal translucency enables the users to examine the thickness with ease. This product reduces your stress during the fit checking process which is usually done repeatedly until a good fit is achieved.

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#### 5. Description of Safety and Substantial Equivalence

The applicant device, Fit Checker Advanced is equivalent to the predicate device, GC Fit Checker II, in its intended use. The applicant device, Fit Checker Advanced, is equivalent to the predicate device, EXA'lence Extra Light Body Regular set in its chemical composition.

#### 5. Performance

## 1) Summary of Performance Specifications

| | Specification | Test method applied | Test results | | Requirement | Conforms |
|---|---------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------|----------------------|-------------|----------|
| | | | GC Fit Checker<br>Advanced | GC Fit<br>Checker II | | |
| 1 | Detail<br>reproduction<br>(μm) | Detail reproduction<br>was measured by the<br>detail reproduction<br>test method in ISO<br>4823 | 20<br>20<br>20 | 20<br>20<br>20 | 20μm | Yes |
| 2 | Elastic<br>recovery<br>(%) | Elastic recovery was<br>measured by the<br>Elastic recovery test<br>method in ISO4823 | 98.9 – 99.3 | 98.5 – 99.6 | ≥96.5 | Yes |
| 3 | Strain in<br>Compression<br>(%) | Strain in compression<br>was measured by the<br>Strain in compression<br>test method in ISO<br>4823 | 4.2 – 4.5 | 6.1 – 6.5 | 2.0-20 | Yes |

As described above, the applicant device, GC Fit Checker Advanced is substantially equivalent to comparative devices, such as GC Fit Checker II and EXA'lence.

#### 4. Shelf Life Evaluation and Storage Conditions:

- Shelf Life 2 years -
- Store in a cool and dark place. 4-25°C (39.2-77.0°F) -

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mark Heiss, DDS Director -Academic and Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

JUN 1 7 2011

Re: K110871

Trade/Device Name: GC Fit Checker Advanced Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 24, 2011 Received: March 29, 2011

Dear Dr. Heiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Heiss

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony O.m

Chilhony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Section 5 - Indications for Use Statement

#### Indications for Use

11/087 510(k) Number (if known):

Device Name:_GC Fit Checker Advanced

Indications for Use:

Checking fit of crowns, bridges, veneers, inlays and dentures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Dunne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110871

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